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Pembrolizumab, a humanized monoclonal antibody against programmed death 1 ( PD ‐1), has been shown to improve overall survival ( OS ) in patients with previously treated advanced non–small‐cell lung cancer ( NSCLC ) with programmed death ligand 1 ( PD ‐L1) tumor proportion score ( TPS ) ≥1%. We report safety and efficacy results from the phase 1b  KEYNOTE ‐025 study, which evaluated pembrolizumab in Japanese patients with previously treated  NSCLC . Eligible patients had histologically/cytologically confirmed advanced  NSCLC  with  PD ‐L1  TPS  ≥1% and had received ≥1 platinum‐doublet chemotherapy. Patients received pembrolizumab 10 mg/kg once every 3 weeks for 2 years or until disease progression/unacceptable toxicity. Primary objectives were to evaluate the safety of pembrolizumab in patients with  PD ‐L1  TPS  ≥1% and the objective response rate ( ORR ) per  RECIST  version 1.1 in patients with  PD ‐L1  TPS  ≥50%. Thirty‐eight patients were enrolled and received ≥1 pembrolizumab dose. The median (range) age was 66.0 (41‐78) years, and 61% had received ≥2 prior systemic therapies. Eleven patients (29%) experienced grade 3‐5 treatment‐related  adverse events (AE) ; 9 patients (24%) experienced immune‐mediated  AE  and infusion reactions, with pneumonitis (11%; any grade) being most common. Among evaluable patients with  PD ‐L1  TPS  ≥50% (n = 11),  ORR  was 27% (95%  CI , 6‐61). Among evaluable patients with  PD ‐L1  TPS  ≥1% (n = 37),  ORR  was 22% (95%  CI , 10‐38). Median (95%  CI ) progression‐free survival and  OS  were 3.9 (2.0‐6.2) months and 19.2 (8.0‐26.7) months, respectively. In summary, pembrolizumab was generally well tolerated and showed promising antitumor activity in Japanese patients with previously treated  PD ‐L1–expressing  NSCLC . Outcomes were consistent with those from the phase 3  KEYNOTE ‐010 study. (Trial registration number: ClinicalTrials.gov, NCT02007070.)

cancer science

KEYNOTE ‐025: Phase 1b study of pembrolizumab in Japanese patients with previously treated programmed death ligand 1–positive advanced non–small‐cell lung cancer